In Promising Trial, Pancreatic Cancer Vaccine Helped Patients Live Longer
As NBC News reported, people with pancreatic cancer survived for an average of 29 months and lived recurrence-free for more than 15 months post-vaccination — far longer than the rates of resectable cancers. A randomized phase 2 trial is being held to test the durability of the vaccine.
NBC News:
Pancreatic Cancer Vaccine Prevents Recurrence In Phase 1 Clinical Trial
In an early trial, a one-size-fits-all vaccine showed promise in preventing hard-to-treat pancreatic cancers from coming back. Pancreatic cancer is of particular concern. The five-year survival rate is about 13%, and up to 80% of pancreatic cancers may come back. ... The vaccine targets one of the most common genetic drivers of cancer: KRAS gene mutations. (Sullivan, 8/11)
Axios:
FDA Says IV Fluid Shortage From Hurricane Is Over
The nationwide shortage of critical intravenous saline fluid triggered by Hurricane Helene is over, though some other injectable solutions remain in shortage almost a year after the storm, the Food and Drug Administration said. (Bettelheim, 8/12)
MedPage Today:
Popular Diabetes Drugs Linked To Small Risk Of Retinal, Optic Nerve Disorders
The risk of new-onset diabetic retinopathy (DR) increased slightly, but significantly, in patients taking GLP-1 receptor agonists for diabetes, despite a lower risk of vision-threatening complications, a large retrospective study suggested. A propensity-matched comparison showed a 7% higher incidence of new DR among users of GLP-1 agonists. The risk of ischemic optic neuropathy did not differ significantly between users and non-users. (Bankhead, 8/11)
Stat:
New Guidelines Call For Stricter Oversight Of Some Stem Cell-Based Research
An influential scientific panel is pumping the brakes on stem cell-based embryo models — an umbrella term for the increasingly complex structures researchers are building from stem cells and growing in the lab to mimic aspects of embryonic development. In new guidelines released Monday, the International Society for Stem Cell Research called for stricter oversight of studies involving such models and the establishment of red lines against using them for certain activities. (Molteni, 8/11)
Also —
ProPublica, Medill Investigative Lab:
Which Drugs Has The FDA Allowed Into The U.S. From Banned Foreign Factories?
For more than a dozen years, the Food and Drug Administration quietly allowed substandard foreign factories to continue shipping medications to the United States even after the agency officially banned them from doing so because of dangerous manufacturing failures. ProPublica exposed the little-known practice in June. The FDA said the decisions to exempt certain medications from import bans were made to fend off drug shortages and that guardrails were in place to ensure the products were safe, such as requiring the banned factories to do extra testing on the drugs before they were sent to Americans. (Cenziper, Rose and Dailey, 8/12)
ProPublica:
Indian Drugmaker Sun Pharma Made Promises To The FDA That It Didn’t Keep
The dispatches from one of India’s most troubled generic drug makers were contrite, filled with far-reaching promises to clean up its factory, stop contamination and send safe medication to Americans counting on the company’s drugs. “We have started addressing FDA concerns very aggressively and comprehensively,” an executive from Sun Pharma wrote to the U.S. Food and Drug Administration in 2015. (Rose and Cenziper, 8/12)
